SX ELLA Esophageal Degradable BD Stent System

Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System

The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.

Inclusion Criteria:

• A recurrent benign esophageal stricture due to all causes (surgery, radiation therapy, corrosive ingestion, peptic injury, PDT, or other ablative therapy)

Exclusion Criteria:

• Patient < 18 years old
• Patient is unwilling or unable to sign and date the informed consent
• Patient is unwilling or unable to comply with the follow-up schedule
• Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 months
• Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
• Patient with a life expectancy < 12 months